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Nanofat Injection and Fractional CO2 Laser for Post-Traumatic Atrophic Scars (NANOCO2-PTS)

30. juni 2026 oppdatert av: Sameh Sarsik, Tanta University

Safety and Efficacy of Nanofat Injection and Fractional CO2 Laser: Monotherapy Versus Combined Therapy in Post-Traumatic Atrophic Scars

Post-traumatic atrophic scars are characterized by skin depressions caused by loss of collagen and can lead to cosmetic and psychological concerns. Several treatment options have been proposed, including fractional carbon dioxide (CO2) laser resurfacing and autologous nanofat grafting, both of which may improve scar appearance through skin remodeling and regeneration. This prospective comparative study evaluates the safety and efficacy of fractional CO2 laser alone, autologous nanofat injection alone, and combination therapy in patients with post-traumatic atrophic scars. Sixty participants were assigned to one of three treatment groups and were assessed using the Vancouver Scar Scale, physician global assessment, patient satisfaction, dermoscopic examination, and histopathological evaluation. The study aims to determine whether combining fractional CO2 laser and nanofat injection provides superior clinical and regenerative outcomes compared with either treatment alone while maintaining an acceptable safety profile.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Post-traumatic atrophic scars are characterized by dermal collagen loss, epidermal thinning, and alterations in skin texture and pigmentation. These scars may result in significant cosmetic disfigurement and negatively affect patients' quality of life. Despite the availability of multiple treatment modalities, no single intervention has consistently demonstrated optimal efficacy.

Fractional carbon dioxide (CO2) laser induces controlled microthermal injury that stimulates collagen remodeling and skin regeneration. Autologous nanofat grafting, which is rich in adipose-derived regenerative cells and growth factors, has emerged as a promising regenerative treatment for improving skin quality and scar remodeling. Combining these two modalities may provide synergistic effects by enhancing tissue regeneration and improving both structural and aesthetic outcomes.

This prospective comparative study was conducted to evaluate and compare the safety and efficacy of fractional CO2 laser monotherapy, autologous nanofat injection monotherapy, and combination therapy in the treatment of post-traumatic atrophic scars. Clinical efficacy was assessed using physician evaluation, Vancouver Scar Scale scores, and patient satisfaction, while dermoscopic and histopathological examinations were performed to investigate treatment-induced structural changes and the mechanisms underlying scar improvement.

The study aimed to determine whether combined therapy offers superior clinical and regenerative outcomes compared with either treatment alone while maintaining an acceptable safety profile.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31527
        • Tanta University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Male or female participants aged 12 years or older.
  • Presence of post-traumatic atrophic scar(s) of at least 6 months' duration.
  • No scar treatment received during the previous 6 months.
  • Willingness and ability to provide written informed consent (or assent with -parental/guardian consent for minors, according to local regulations).
  • Willingness to comply with study procedures and follow-up assessments.

Exclusion Criteria:

  • Hemoglobin <10 g/dL.
  • Active infection or viral skin disease.
  • Coagulopathy or hemophilia.
  • Current anticoagulant therapy.
  • Diabetes mellitus.
  • History of keloid formation.
  • History of malignancy or prior radiation therapy.
  • Immunosuppression.
  • Long-term systemic corticosteroid therapy.
  • Photosensitivity disorders.
  • Pregnancy or breastfeeding.
  • Renal or hepatic disease.
  • Systemic diseases affecting wound healing.
  • Thin patients with insufficient adipose tissue for adipose tissue harvesting.
  • Previous scar treatment within the preceding 6 months.
  • Use of systemic retinoids within the preceding 6 months. -Use of topical retinoids within the preceding 2 weeks.-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Fractional CO2 Laser
Participants will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals.
Enhet: Fractional CO2 Laser
Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.
Andre navn:
  • Fractional Carbon Dioxide Laser
Aktiv komparator: Autologous Nanofat Injection
Participants will receive one session of autologous nanofat injection for treatment of post-traumatic atrophic scars.
Biologisk: Autologous Nanofat Injection
A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
Andre navn:
  • Autologous Nanofat
Aktiv komparator: Fractional CO2 Laser + Autologous Nanofat Injection
Participants will receive three sessions of fractional carbon dioxide laser at one-month intervals followed by one session of autologous nanofat injection.
Enhet: Fractional CO2 Laser
Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.
Andre navn:
  • Fractional Carbon Dioxide Laser
Biologisk: Autologous Nanofat Injection
A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
Andre navn:
  • Autologous Nanofat

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Vancouver Scar Scale Score
Tidsramme: Baseline and 3 months after completion of treatment
The change in scar severity assessed using the Vancouver Scar Scale (VSS), including vascularity, pigmentation, and pliability, from baseline to the post-treatment assessment.
Baseline and 3 months after completion of treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physician Global Assessment of Clinical Improvement
Tidsramme: 3 months after completion of treatment
Clinical improvement evaluated by three blinded dermatologists using a quartile grading scale (poor: 0-25%, fair: 25-50%, good: 50-75%, excellent: 75-100% improvement).
3 months after completion of treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tanta University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

28. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

25. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TANTA-33465-11-19
  • TU-DERM-PTAS-2020-01 (Registeridentifikator: Internal Protocol Number)
  • 33465/11/19 (Annen identifikator: Ethics Approval Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared publicly because participant consent for public data sharing was not obtained and the dataset contains potentially identifiable information.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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